Scorpion
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.[2]
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Overview
Scorpion is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of ANASCORP® [centruroides (scorpion) immune F(ab')2 (equine) injection] is an equine-derived antivenom indicated for treatment of patients with clinical signs of scorpion envenomation.. Common adverse reactions include The most common adverse reactions observed in ≥ 2% of patients in the clinical studies for ANASCORP were: vomiting, pyrexia, rash, nausea and pruritus..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
For Intravenous use only.
Initiate treatment with ANASCORP as soon as possible after scorpion sting in patients who develop clinically important signs of scorpion envenomation, including but not limited to loss of muscle control, roving or abnormal eye movements, slurred speech, respiratory distress, excessive salivation, frothing at the mouth and vomiting.(2)
Initial Dose: 3 vials
The initial dose of ANASCORP is 3 vials. Reconstitute the contents of each vial with 5 milliliters of sterile normal saline (0.9% NaCl) and mix by continuous gentle swirling. Combine the contents of the reconstituted vials promptly and further dilute to a total volume of 50 milliliters with sterile normal saline (0.9% NaCl). Inspect the solution visually for particulate matter and discoloration prior to administration. Do not use if turbid. Infuse intravenously over 10 minutes. Monitor patient closely during and up to 60 minutes following the completion of infusion to determine if clinically important signs of envenomation have resolved. Discard partially used vials.
Additional Dosing
Additional doses may be used if needed. Infuse one vial at a time at intervals of 30 to 60 minutes. Reconstitute the contents with 5 milliliters of sterile normal saline (0.9% NaCl) and mix by continuous gentle swirling. Further dilute to a total volume of 50 milliliters with sterile normal saline (0.9% NaCl). Inspect the solution visually for particulate matter or discoloration prior to administration. Infuse intravenously over 10 minutes. Monitor patient closely during and up to 60 minutes following the completion of infusion to determine if clinically important signs of envenomation have resolved. Discard partially used vials.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Scorpion FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
None
Warnings
5.1 Hypersensitivity Reactions Severe hypersensitivity reactions, including anaphylaxis, may occur with ANASCORP. Close patient monitoring for hypersensitivity reactions and readiness with intravenous therapy using epinephrine, corticosteroids, and diphenhydramine hydrochloride is recommended during the infusion of ANASCORP. If an anaphylactic reaction occurs during the infusion, terminate administration at once and administer appropriate emergency medical care.
Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. Patients who have had previous therapy with ANASCORP or another equine antivenom/antitoxin may have become sensitized to equine protein and be at risk for a severe hypersensitivity reaction.
5.2 Delayed Allergic Reactions (Serum Sickness) Monitor patients with follow-up visit(s) for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia), and treat appropriately if necessary. Eight out of 1,534 (0.5%) patients in the clinical trials exhibited symptoms suggestive of serum sickness. (6.1)
5.3 Transmissible Infectious Agents ANASCORP is made from equine (horse) plasma, it may therefore carry a risk of transmitting infectious agents, e.g., viruses.
5.4 Reaction to Cresol Trace amounts of cresol from the manufacturing process are contained in ANASCORP. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.
Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 1534 patients were treated with ANASCORP, ranging from less than one month to 90 years old. The patient population was comprised of 802 males and 732 females. Patients were monitored for signs and symptoms of adverse reactions, including acute hypersensitivity reactions and serum sickness. Follow-up telephone interviews were conducted at 24 hours, 7 days, and 14 days after treatment to assess symptoms suggestive of ongoing venom effect, serum sickness, and any other adverse reactions.
Table 1 shows the adverse reactions occurring in patients across all clinical trials for ANASCORP. Twenty-seven percent (421/1534) of patients receiving ANASCORP reported at least one adverse reaction.
No patients died or discontinued study participation for severe adverse reactions.
Eight patients were considered to have serum sickness (Type III hypersensitivity); no patient manifested the full serum sickness syndrome. Three patients were treated with systemic corticosteroids and five others received either no treatment or symptomatic therapy.
34 patients experienced a total of 39 severe adverse reactions such as respiratory distress, aspiration, hypoxia, ataxia, pneumonia, and eye swelling. It is not clear whether these adverse reactions were related to ANASCORP envenomation or a combination of both2.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of ANASCORP . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Chest tightness, palpitations, rash and pruritus.
Drug Interactions
No drug interaction studies have been conducted with ANASCORP.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Animal reproduction studies have not been conducted with ANASCORP. It is also not known whether ANASCORP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ANASCORP should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Scorpion in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Scorpion during labor and delivery.
Nursing Mothers
It is not known whether ANASCORP is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when ANASCORP is administered to a nursing woman.
Pediatric Use
Seventy-eight percent of the patients enrolled in the clinical studies were pediatrics subjects(1204/1534), with ages ranging from less than one month to 18.7 years of age. Patient age groups were as follows: < 2 years of age, 29%, 2 to 5 years, 37%, 5 to 18 years, 34%. The efficacy and safety of ANASCORP is comparable in pediatric and adult patients.
Geriatic Use
Specific studies in elderly patients have not been conducted, ANASCORP was administered to 77 patients over the age of 65 years with comparable efficacy and safety to the overall patient population.
Gender
There is no FDA guidance on the use of Scorpion with respect to specific gender populations.
Race
There is no FDA guidance on the use of Scorpion with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Scorpion in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Scorpion in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Scorpion in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Scorpion in patients who are immunocompromised.
Administration and Monitoring
Administration
For Intravenous use only.
Initiate treatment with ANASCORP as soon as possible after scorpion sting in patients who develop clinically important signs of scorpion envenomation, including but not limited to loss of muscle control, roving or abnormal eye movements, slurred speech, respiratory distress, excessive salivation, frothing at the mouth and vomiting.(2)
Initial Dose: 3 vials
The initial dose of ANASCORP is 3 vials. Reconstitute the contents of each vial with 5 milliliters of sterile normal saline (0.9% NaCl) and mix by continuous gentle swirling. Combine the contents of the reconstituted vials promptly and further dilute to a total volume of 50 milliliters with sterile normal saline (0.9% NaCl). Inspect the solution visually for particulate matter and discoloration prior to administration. Do not use if turbid. Infuse intravenously over 10 minutes. Monitor patient closely during and up to 60 minutes following the completion of infusion to determine if clinically important signs of envenomation have resolved. Discard partially used vials.
Additional Dosing
Additional doses may be used if needed. Infuse one vial at a time at intervals of 30 to 60 minutes. Reconstitute the contents with 5 milliliters of sterile normal saline (0.9% NaCl) and mix by continuous gentle swirling. Further dilute to a total volume of 50 milliliters with sterile normal saline (0.9% NaCl). Inspect the solution visually for particulate matter or discoloration prior to administration. Infuse intravenously over 10 minutes. Monitor patient closely during and up to 60 minutes following the completion of infusion to determine if clinically important signs of envenomation have resolved. Discard partially used vials.
Monitoring
There is limited information regarding Scorpion Monitoring in the drug label.
IV Compatibility
For Intravenous use only.
Overdosage
There is limited information regarding Scorpion overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Scorpion Pharmacology in the drug label.
Mechanism of Action
ANASCORP is composed of venom-specific F(ab')2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body.1
Structure
There is limited information regarding Scorpion Structure in the drug label.
Pharmacodynamics
There is limited information regarding Scorpion Pharmacodynamics in the drug label.
Pharmacokinetics
Eight clinically healthy volunteers (6 males and 2 females, age: 17 to 26 years) received a bolus intravenous dose of 47.5 mg of centruroides (scorpion) immune F(ab’)2, (equine) injection. Blood samples were collected till 504 hours (21 days) and pharmacokinetic parameters were estimated by non-compartmental analysis
Nonclinical Toxicology
There is limited information regarding Scorpion Nonclinical Toxicology in the drug label.
Clinical Studies
The efficacy of ANASCORP was assessed in a prospective double-blind randomized placebo-controlled study, four open-label studies and one retrospective study in various treatment settings in the United States and Mexico, where scorpion envenomation is common. A total of 1534 patients ranging from less than one month to 90 years old were treated. The majority of patients (78%, 1204/1534) were pediatric, ranging from less than one month to 18.7 years of age. Male (52.3%) and female patients (47.7%) were equally represented. Treatment success was determined by resolution of clinically important signs of scorpion envenomation within four hours of starting infusion. The randomized placebo study enrolled 15 subjects, eight to the ANASCORP treated group and seven to the placebo. The symptom resolution success rate was 100% for the ANASCORP treated and 14.3% for the placebo group.
A retrospective hospital chart review provided historical data from envenomated patients (n=97) who did not receive antivenom but were treated with sedatives and supportive care for symptoms of envenomation. These data were used as a historical control for expected outcomes in the absence of antivenom treatment. The historical controls were pediatric patients admitted to two pediatric intensive care units between 1990 and 2003 for the treatment of scorpion envenomation with supportive care only. The proportion of patients that required intensive care support four hours after intensive care unit admission, and the overall duration of the intensive care support requirement were calculated.
Overall, 95-100% of patients were relieved of systemic signs associated with scorpion envenomation in less than four hours after initiating ANASCORP treatment. In the historical control database, only 3.1% of patients experienced relief of symptoms within 4 hours of hospital admission.
In 1396/1534 patients the mean time from start of ANASCORP infusion to resolution of clinical signs and symptoms of envenomation was 1.42 hours (0.2 to 20.5 hours). Pediatric patients generally experienced a slightly faster time to resolution (1.28 ± 0.8 hours) compared with that of adult patients (1.91 ±1.4 hours). The time to resolution of symptoms was not affected by use of sedatives (474 patients who received sedatives resolved in 1.49 ± 1.1 hours and 922 patients who did not receive sedatives resolved in 1.38 ± 0.9 hours).
How Supplied
ANASCORP is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted, each vial contains not more than 7.0 milligrams per milliliter of protein, and not less than 150 mouse LD50 neutralizing units.
Each carton NDC 66621-0150-2 contains 1 vial of ANASCORP NDC 66621-0150-1.
Storage
Store at room temperature (up to 25 ºC (77 ºF)). Brief temperature excursions are permitted up to 40 ºC (104ºF). DO NOT FREEZE. Discard partially used vials.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Serious Allergic Reactions Advise patients to contact the physician or emergency department immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness up to 14 days following hospital discharge. Symptoms include rash, pruritus, joint pain, arthralgia, fever, lymphadenopathy, and malaise
Precautions with Alcohol
Alcohol-Scorpion interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Scorpion Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Scorpion Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.